EXTRAPOLATION OF CLINICAL DATA FOR PEDIATRIC USES: APPLICATION FOR MEDICAL DEVICES AND DRUG PRODUCTS

| October 18, 2016

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The Food and Drug Administration released the revised draft guidance entitled ‘‘Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices” on June 21, 2016 (Docket No. FDA–2015–D–1376). This guidance explains the circumstances in which appropriate extrapolation of medical.

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Guerbet

Guerbet is a human-scale company that aims to become a new global leader in medical imaging. Pioneer in contrast media with 90 years'​ experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors.

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